Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Incidence of CRBSIs
研究概览
简要总结
The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.
详细描述
Recently, a silver zeolite-impregnated catheter has been commercialized. This material, namely the patented silver compound AgION™, releases antimicrobially active silver ions which may help prevent catheter-related bloodstream infections CRBSIs which are frequent in preterm infant.
The investigators hypothesized that the use of AgION-impregnated umbilical catheters could decrease the occurrence of CRBSIs in preterm infants. To assess this hypothesis the investigators carried out a randomized controlled study in which preterm infants needing an umbilical vein catheter would received either an AgION catheter or a traditional non-impregnated polyurethane catheter.
Infants with gestational age < 30 weeks were randomized to receive an AgION- impregnated or non-impregnated polyurethane umbilical venous catheter (UVC) by opening sealed opaque envelopes. The primary end point was the incidence of CRBSIs during the time the UVC was in place.
The investigators studied 86 infants, 41 of whom received the AgION catheter and 45 the non-impregnated catheter. During umbilical venous catheterization 2% of infants in the AgION group developed CRBSI in comparison with 22% of infants in the control group (p=0.005). The incidence density of CRBSIs during the study period was lower in infants who received AgION catheters compared to the control group (2.1/1000 catheter days versus 25.8/1000 catheter days; p<0.001). The occurrence of UVC colonization was similar in both groups. The Kaplan-Meier estimates of the cumulative likelihood of being free of a CRBSI at each day of UVC placement demonstrate the statistically significant (p=0.004) protective effect of AgION impregnated catheters. Moreover, infants in the AgION group had shorter hospital stay (p=0.04), and a lower case fatality rate due to BSI (p=0.01) than infants in the control group.
AgION catheters were well tolerated and none of patients showed signs attributable to silver toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 30 weeks
- •Need of an umbilical venous catheter in the first week of life
- •Parental informed consent.
排除标准
- •Major congenital malformations
- •Hydrops fetalis
- •Inherited congenital metabolic diseases
- •Death during the first week of life
研究组 & 干预措施
AgION catheter
Patients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
干预措施: Umbilical catheterization (AgION ) (Device)
Non-impregnated polyurethane catheter
Patients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
干预措施: Umbilical catheterization (ArgyleTM) (Device)
结局指标
主要结局
Incidence of CRBSIs
时间窗: Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
We evaluated the incidence of CRBSIs (definite plus probable) during the time the UVC was in place.
次要结局
- Case fatality rate for infants with CRBSI(Hospital stay duration, an expected average of 80 days)
- AgION catheters tolerability(Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days)
- Infection density(Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days)
- Likelihood of freedom from CRIBSIs(Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days)
研究者
Carlo Dani
Associate Professor of Pediatrics
University of Florence